Time to pain freedom and onset of pain relief with rizatriptan 10 mg and prescription usual-care oral medications in the acute treatment of migraine headaches: a multicenter, prospective, open-label, two-attack, crossover study. Clin Ther
Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy.
This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings.
This was a multicenter, prospective, open-label study. Adult patients treated 2 sequential migraine attacks with rizatriptan 10 mg and a usual-care prescription migraine medication in a crossover manner. Patients chose which medication to take first. They recorded the treatment outcomes using a stopwatch and a treatment diary. End points included time to pain freedom (length of time from dosing to no pain) and time to onset of pain relief (mean time to onset of pain relief and proportion of patients reporting onset of pain relief at 30 minutes), satisfaction with treatment, and medication preference. Information on adverse events was collected through the normal post-marketing reporting mechanism. Comparisons were made using the paired t test and McNemar test for continuous and categorical variables, respectively. A mixed model, accounting for multiple observations per patient, was fitted for the time to pain freedom, controlling for age, sex, treatment period, medication, and headache severity.
Of 2346 enrolled patients, 1489 treated 2 migraines in a crossover manner and were included in the analysis (86.8% women, 13.2% men; mean age, 41.7 years). A majority of patients (80.6%) treated both migraines with oral triptans. The most commonly used nontriptans were NSAIDs (5.4%), butalbital-containing combinations (4.3%), and isometheptene (3.4%). Over-the-counter medications were used by 22.3% of patients during rizatriptan-treated attacks and by 28.9% of patients during attacks treated with usual-care medications. The mean time to pain freedom was significantly shorter when an attack was treated with rizatriptan compared with usual-care medications (222 vs 298 minutes, respectively; P<0.001), and the onset of pain relief was significantly more rapid (85 vs 107 minutes; P=0.003), with significant differences noted as early as 15 minutes after dosing (P<0.001). The findings remained similar after adjustment for potential confounding factors. No significant sequence effect was detected. Significantly more patients reported being very satisfied or satisfied with rizatriptan compared with usual-care medications (65.4% vs 57.7%; P<0.001) and preferred rizatriptan (58.0% vs 42.0%; P<0.001). One female patient reported having hives and itchy skin the day after taking rizatriptan; the symptoms subsided after treatment with methylprednisolone.
In this selected population, treatment of a migraine attack with rizatriptan 10 mg was associated with a faster time to pain freedom and onset of pain relief compared with treatment with usual-care oral migraine medications. Patients reported greater satisfaction with and preference for rizatriptan.
"For the non-RDB acute trials reviewed here, however, the average number of treated patients is 556, i.e. larger than the overall average of the acute trials. Three huge studies of more than 2,300 subjects each contribute to this average [18, 53, 72]. One of these trials scored a total of 0 on the rating scale used in this review. "
[Show abstract][Hide abstract] ABSTRACT: In 2000, the Clinical Trials Subcommittee of the International Headache Society (IHS) published the second edition of its guidelines for controlled trials of drugs in migraine. The purpose of this publication was to improve the quality of such trials by increasing the awareness amongst investigators of the methodological issues specific to this particular illness. Until now the adherence to these guidelines has not been systematically assessed. We reviewed all published controlled trials of drugs in migraine from 2002 to 2008. Eligible trials were scored for compliance with the IHS guidelines by using grading scales based on the most essential recommendations of the guidelines. The primary efficacy measure of each trial was also recorded. A total of 145 trials of acute treatment and 52 trials of prophylactic treatment were eligible for review. Of the randomized, double-blind trials, acute trials scored an average of 4.7 out of 7 while prophylactic trials scored an average of 5.6 out of 9 for compliance. Thirty-one percent of acute trials and 72% of prophylactic trials used the recommended primary efficacy measure. Fourteen percent of the reviewed trials were either not randomized or not double-blinded. Adherence to international guidelines like these of IHS is important to ensure that only high-quality trials are performed, and to provide the consensus that is required for meta analyses. The primary efficacy measure for trials of acute treatment should be "pain free" and not "headache relief". Open-label or non-randomized trials generally have no place in the study of migraine drugs.
The Journal of Headache and Pain 10/2010; 11(6):457-68. DOI:10.1007/s10194-010-0257-5 · 2.80 Impact Factor
"The most common reasons cited for preference were faster relief of headache and faster return to normal function. A similar study by Bell and colleagues14 compared rizatriptan 10 mg tabs with usual-care medications. These medications included sumatriptan (48.9%), zolmitriptan (15.8%), eletriptan (12.9%), almotriptan (12.0%), "
[Show abstract][Hide abstract] ABSTRACT: Rizatriptan is a 5HT (IB/ID) agonist with proven efficacy in the acute treatment of migraine headache. We performed a systematic review of the literature for clinical trials of rizatriptan incorporating important patient outcomes including consistency of response, preference, satisfaction, and quality of life. We found evidence that rizatriptan provides consistent relief of migraine attacks and that patients prefer rizatriptan over other treatments because of its speed of relief. Patient satisfaction with rizatriptan is significantly higher than placebo, but appears equivalent to most other triptans. Migraine-specific quality of life at 24 hours is significantly better in patients treated with rizatriptan compared to placebo, while overall long-term quality of life is less affected. The published clinical trials included in this systematic review are subject to bias due to the open-label nature of preference trials and the doses chosen for comparison in head-to-head trials.
[Show abstract][Hide abstract] ABSTRACT: In the clinical trial setting, oral rizatriptan 10 mg has greater efficacy than other oral triptans in freedom from migraine headache pain 2 h after dosing.
The study objective is to compare the effectiveness of rizatriptan 10 mg and other oral triptans for acute migraine attack in a naturalistic setting.
A total of 673 patients took rizatriptan 10 mg or their usual-care oral triptans for two migraine attacks in a sequential, cross-over manner and recorded outcomes using a diary and a stopwatch. Mean and median times to pain relief (PR) and pain freedom (PF) for rizatriptan and other oral triptans were compared. The effect of rizatriptan on times to PR and PF, adjusting for potential confounding factors (treatment sequence, treatment order and use of rescue medication), was computed via a Cox proportional hazard model.
Significantly, more patients taking rizatriptan achieved both PR and PF within 2 h after dosing than other oral triptans. Times to PR and PF were shorter with rizatriptan than with other oral triptans (median time to PR: 45 vs. 52 min, p < 0.0001; median time to PF: 100 vs. 124 min, p < 0.0001). The adjusted proportional hazard ratios (rizatriptan vs. other oral triptans) for times to PR and PF were 1.32 (95% CI: 1.22-1.44) and 1.27 (95% CI: 1.16-1.39) respectively.
The times to PR and PF in a 'naturalistic' setting were significantly shorter for patients treating a migraine attack with rizatriptan 10 mg than with other oral triptans.
International Journal of Clinical Practice 08/2007; 61(7):1091-111. DOI:10.1111/j.1742-1241.2007.01400.x · 2.57 Impact Factor
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